Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation
NCT ID: NCT04554758
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2020-09-01
2023-08-31
Brief Summary
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Detailed Description
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The principal investigator or another clinical investigator in charge will individually inform the patients about the study, before operation at out patient clinic. At that time patient is selected to either sleeve gastrectomy group or Roux-en-Y gastric bypass group. All investigator report to clinical research center about patients BMI and operation method.
About 30-35 obesity patients will be enrolled according to their BMI status. Patients' BMI status is classified into several parts by 2.5 gap started from 27.5.
All patients will undergo periodically anthropometry, laboratory tests, bioelectrical impedance analysis, gastrofiberscopy, polysomnography and abdomen CT before and after surgery.
Patients with hypertension will undergo echocardiography. Patients with polycystic ovary syndrome will be checked hormonal study. Patients with type 2 diabetes mellitus will be performed 75g oral glucose tolerance test test.
Surgical complication include wound morbidities, gastrointestinal leakage or fistula, postoperative bleeding, intra-abdominal abscess, stricture , adhesive ileus, reflux esophagitis, marginal ulceration, dumping syndrome and internal hernia.
Systemic complication which is not associated with the operation field include ling morbidities, heart morbidities, urinary morbidities and others.
Hospital mortality is defined as postoperative death form any cause within 30 days after operation.
All patients will be followed up post operative 1 month, 3 month, 6 month, 12 month, 18 month, 24 month.
All patients' liver tissue, visceral fat and subcutaneous fat will be harvested during operation.
All patients' blood sample will be collected at out patient clinic visit. All patients' urine and face will be collected at out patient clinic visit and will be analyzed to evaluate microbial change throughout pre and post operation period.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sleeve gastrectomy
200 obesity patients who undergo laparoscopic sleeve gastrectomy
Sleeve gastrectomy
Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.
Roux-en-Y gastric bypass
200 obesity patients who undergo laparoscopic Roux-en-Y gastric bypass
Roux-en-Y gastric bypass
Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.
Interventions
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Sleeve gastrectomy
Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.
Roux-en-Y gastric bypass
Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.
Eligibility Criteria
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Inclusion Criteria
* morbid obesity patients(BMI over 30) with cardiovascular disease, hypertension, hyperlipidemia, type 2 diabetes mellitus, obstructive sleep apnea
* type 2 diabetes mellitus obesity patients(BMI over 27.5) who were treated medical therapy or HbA1C level over 7%
Exclusion Criteria
* Patients who were diagnosed malignant disease patients within 5 years
* Patients who were involved with other clinical trial within 3 months
* Patients who are risky to conduct general anesthesia for operation
20 Years
65 Years
ALL
No
Sponsors
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Korean Center for Disease Control and Prevention
OTHER_GOV
Inha University Hospital
OTHER
Responsible Party
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Yoonseok Heo
Professor
Principal Investigators
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Yoon Seok Heo, Professor
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Do Joong Park, Professor
Role: STUDY_DIRECTOR
Seoul National University Hospital
Yong Suk Park, Professor
Role: STUDY_DIRECTOR
Seoul National University Bundang Hospital
Seung Wan Ryu, Professor
Role: STUDY_DIRECTOR
Keimyung University Hospital
Moon Won Yoo, Professor
Role: STUDY_DIRECTOR
Ulsan univertisy Seoul Asan Medical Center
Han Hong Lee, Professor
Role: STUDY_DIRECTOR
The Catholic University of Korea
Ji Yeon Park, Professor
Role: STUDY_DIRECTOR
Kyungpook National University Hospital
Sang Hyun Kim, Professor
Role: STUDY_DIRECTOR
Soonchunhyang University Hospital
Jong Won Kim, Professor
Role: STUDY_DIRECTOR
Chung-Ang University Hopspital
Jong Han Kim, Professor
Role: STUDY_DIRECTOR
Korea University Medical Center(Guro Hospital)
In Seob Lee, Professor
Role: STUDY_DIRECTOR
Ulsan univertisy Seoul Asan Medical Center
In Gyu Kwon, Professor
Role: STUDY_DIRECTOR
Yonsei University Medical Center(Gangnam Hospital)
Tae Kyung Ha, Professor
Role: STUDY_DIRECTOR
Hanyang University
Sung Il Choi, Professor
Role: STUDY_DIRECTOR
Kyung Hee University Hospital at Gangdong
Kyung Won Seo, Professor
Role: STUDY_DIRECTOR
Kosin University Gospel Hospital
Locations
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Inha University Hospital
Incheon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KOBESS-II trial
Identifier Type: -
Identifier Source: org_study_id
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